See us at MedTechDagen 25 September!
GBA Key2Compliance is proud to be a partner of MedTechdagen and we look forward to being on-site when the industry’s leading companies, researchers, and decision-makers gather to discuss the future of medical technology, innovations, and regulatory challenges. At the same time, Medtech Magazine is celebrating its 20th anniversary, making this event even more special. Take […]
Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
Join our Workshop on Building Clinical Evidence for MedTech!
Join us for a hands-on morning session designed to support MedTech startups and scale-ups as they take their first steps toward clinical investigation. Whether you’re preparing for your first-in-human study or planning your clinical strategy, this event will help you avoid common pitfalls and focus on what really matters to succeed. You’ll hear from experienced […]
From Prototype to Patient – Building Clinical Evidence for Medical Devices
Save the date – A half-day event for MedTech startups and scale-ups preparing for clinical investigations We’re happy to invite you to a hands-on morning session focused on essential – and often overlooked – parts of the clinical development journey before CE-marking. What we’ll cover Early Clinical Strategy – What must be in place before […]
Join GBA Key2Compliance at GoCo’s Open House Event!
We’re thrilled to invite you to join us at GoCo Health Innovation City’s Open House event on May 13. For the second year in a row, the companies at GoCo are opening their doors to showcase the dynamic ecosystem we’re building together. You’re invited to take part – free of charge. Join us for a […]
GBA Key2Compliance at RAPS Euro Convergence 2025 in Brussels!
GBA Key2Compliance is excited to attend RAPS Euro Convergence 2025 in Brussels! Join us from May 13-16 for Europe’s most comprehensive regulatory affairs conference, focusing on the latest developments and topics in healthcare products across Europe and beyond. Visit us at Booth #5 Our team – Helena Dahlin, Director Quality Assurance & Regulatory Affairs, and […]
Webinar: Why Most Device Start-up Companies Struggle to Survive – Ways to Thrive and Prosper!
In the MedTech industry, 8 out of 10 start-up companies don’t make it past their first 7 years. Why do so many fail, and how can you avoid the most common pitfalls? Join experienced speakers from GBA Key2Compliance and BAAT Medical for a deep dive into the challenges start-ups face and discover strategies to thrive. […]
How ISO13485 prepares your IVDR Quality System for audits and what it doesn’t cover
Register today! May 27, 2025 10:30 – 11:15 CET Join our Free Webinar on IVDR Compliance for In Vitro Diagnostic Medical Device Manufacturers With the upcoming IVDR compliance deadline at the end of May, it’s crucial to ensure your organization is fully prepared. This webinar will provide a comprehensive overview of the most critical aspects […]
Join Our Free BioComp Bootcamp Webinar Series!
Are you working with biocompatibility or clinical evaluation in the medical device industry? Our BioComp Bootcamp webinar series is designed to help you stay informed and up to speed—quickly and efficiently. Each 20-minute session dives into a key topic, providing valuable insights, expert guidance, and practical resources to support your work. Why Join? Short & […]
Meet Us at Regulatory Summit 2025!
GBA Key2Compliance is looking forward to participating in this year’s Regulatory Summit, organized by Swedish Medtech. Now in its 8th edition, this event is one of the most important meeting places of the year for industry experts and leaders to discuss and analyze the challenges and changes related to MDR. As a Networking Partner to […]